Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT02776202
Eligibility Criteria:
Inclusion Criteria:
* 1\. SCD patients who are 3-18 years old. 2. SCD (HbSS, HbSβ° thalassemia or any genotype) with at least one of the following conditions:
1. Clinically significant neurologic event (stroke) or any neurologic defect lasting \> 24 hours and accompanied by an infarct on cerebral magnetic resonance imaging (MRI)
2. Minimum of two episodes of acute chest syndrome within the preceding 2-year period defined as new pulmonary alveolar consolidation involving at least one complete lung segment (associated with acute symptoms including fever, chest pain, tachypnea, wheezing, rales or cough that is not attributed to asthma or bronchiolitis) despite adequate supportive care measures
3. History of 3 or more severe pain events per year in the 2 years prior to enrollment.
3\. Availability of 10/10 genotypically HLA identical related donor 4. In patients who have been treated by regular RBC transfusions \>12 months, with a liver biopsy that shows no evidence of cirrhosis or active hepatitis 5. Patients must have a Karnofsky score ≥ 50 or WHO/ECOG ≥ 2 for patients age ≥ 16, Lansky score ≥ 50 for patients age \< 16.
6\. Adequate cardiac function: shortening fraction of \> 25% or ejection fraction of \> 55% by echocardiogram 7. Adequate renal function: serum creatinine within normal limits or creatinine clearance \>70 ml/min/1.73 m2 8. Adequate liver function: Total bilirubin within normal limits and AST/ALT \<2.5x upper limit of normal
Exclusion Criteria:
* 1\. Patients with symptomatic cardiac insufficiency or arrhythmia. 2. Patients with cirrhosis on liver biopsy. 3. Hepatitis B, hepatitis C, or HIV seropositive patients. 4. Patients with other disease that would increase toxicity of transplant.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
18 Years
Study:
NCT02776202
Study Brief:
Protocol Section:
NCT02776202